Guidelines for the Pharmacovigilance Safety Review Committee

1) Purpose

The purpose of this SOP is to establish standardized procedures for the functioning of the Safety Review Committee (SRC) to ensure comprehensive evaluation and decision-making on safety-related issues.

2) Scope

This SOP applies to all members of the Safety Review Committee and other pharmacovigilance personnel involved in the SRC process.

3) Responsibilities

The Safety Review Committee (SRC) is responsible for reviewing safety data, identifying potential risks, and making recommendations for risk management. The Pharmacovigilance (PV) Manager coordinates the SRC meetings and ensures compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Formation of the Safety Review Committee

1. Establish the SRC with representatives from key functional areas, including pharmacovigilance, clinical development, regulatory affairs, and medical affairs.
2. Appoint a Chairperson and a Secretary for the SRC.
3. Document the roles and responsibilities of SRC members in an SRC charter.

4.2 Scheduling and Preparation for SRC Meetings

1. Schedule regular SRC meetings (e.g., monthly, quarterly) and ad hoc meetings as needed.
2. Prepare and distribute meeting agendas, including a list of safety topics to be discussed.
3. Collect and review relevant safety data and reports prior to the meeting.

4.3 Conducting SRC Meetings

1. Convene SRC meetings with all members in attendance.
2. Review and discuss the safety data and reports presented.
3. Identify potential safety signals and evaluate their impact on the benefit-risk profile of the medicinal product.
4. Document the discussions, decisions, and action items in meeting minutes.

4.4 Decision-Making and Recommendations

1. Make decisions on safety-related issues based on the evaluation of safety data.
2. Recommend risk management measures, such as changes to product labeling, additional studies, or safety communications.
3. Document the decisions and recommendations in the SRC meeting minutes.

4.5 Implementation and Follow-Up

1. Communicate the SRC decisions and recommendations to relevant stakeholders, including regulatory authorities, healthcare professionals, and internal teams.
2. Ensure the implementation of the recommended risk management measures.
3. Monitor the effectiveness of the implemented measures and provide updates to the SRC.

4.6 Documentation and Record Keeping

1. Maintain detailed records of SRC meetings, including agendas, meeting minutes, and action items.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.

4.7 Quality Control

1. Conduct regular quality control checks on the SRC process to ensure accuracy and consistency.
2. Address any discrepancies or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.8 Training and Communication

1. Communicate SRC procedures and updates to all relevant staff members.
2. Provide training on SRC processes and decision-making to ensure consistency and quality.
3. Report any issues or challenges encountered during the SRC process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance
SRC – Safety Review Committee

6) Documents, if any

SRC charter, meeting agendas, meeting minutes, action item logs.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module IX.

8) SOP Version

Version 1.0